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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
510(k) Number K190960
Device Name Nalu Lead Blank (50cm)
Applicant
Nalu Medical, Inc.
2320 Faraday Ave., Suite 100
Carlsbad,  CA  92008
Applicant Contact Sunny Gill
Correspondent
Nalu Medical, Inc.
2320 Faraday Ave., Suite 100
Carlsbad,  CA  92008
Correspondent Contact Sunny Gill
Regulation Number882.5880
Classification Product Code
GZB  
Date Received04/12/2019
Decision Date 07/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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